GxP Lifeline

15 November, 2018
by Joy McElroy, Consultant and Business Development Director, Maynard Consulting Company

Consumers and patients assume manufactured pharmaceuticals are safe and effective. In order for quality units to assure this, you have to have a robust quality control (QC) and quality assurance (QA) program guided by an equally sound quality management system (QMS). Learn the roles of QC and QA and how to create a QMS that will help your company maintain a high level of quality.

Rather than viewing ISO as a burden, think of it as a standard upon which you can build a foundation for the sustainability and growth of your business. Learn how to use ISO as a catalyst to align a quality management system (QMS) with the strategic direction of your company.

One of the major technological trends beginning to impact the pharmaceutical industry is artificial intelligence (AI). Analysts say it isn’t a matter of if but when AI will become a game-changer for pharma companies, particularly when it comes to slashing the time and costs involved with drug discovery. Find out what your company can do to best plan for AI’s anticipated revolutionary impact on drug development.

The inclusion of software in medical devices is opening up new avenues for health care treatments. However, it also means medical devices are becoming more complex. New innovations in medical device development should compel device manufacturers to revamp their design and development strategies. More time and effort needs to be spent on design control, risk management and cybersecurity. The increase of software in medical devices will a noticeable impact on the approaches to medical device design and manufacturing.

It’s said that change is never easy. But in the pharmaceutical industry, flexibility, and adaptability are part and parcel of successfully delivering the safest, highest quality products to a global market.

Both the European Compliance Academy (ECA) and the European Qualified Person association (EQPA) are often contacted by people who would like to become a Qualified Person (QP according the EU Directives) outside of the EU. Is this possible?

It’s impossible to know exactly what future trends will influence the direction and methodologies of quality assurance (QA). However, according to Bristol Myers Squibb executive Donna Gulbrinski, looking at how quality professionals overcome current challenges can lend some insight on future QA strategies and processes.

The U.S. Food and Drug Administration (FDA) has been protecting American consumers for over 100 years. In the face of increasing global interdependence, the FDA’s responsibility has expanded by necessity; it works with its counterparts throughout the world to help ensure product safety and quality.

Using ISO parlance, a management system is designed to achieve objectives. In the case of a quality management system (QMS), the most basic objective is to succeed by satisfying customers. A QMS is a system designed to satisfy customers by providing them with timely, quality products and services.

By now, we all know that risk-based monitoring (RBM) isn’t just about changing the role of the clinical research associate (CRA); it’s transforming the way clinical studies are managed. So what does that mean for quality assurance (QA) teams who audit these new processes? Polaris president Celine Clive led a roundtable discussion about RBM and its implications for auditing at November’s North Carolina Regulatory Affairs Forum (NCRAF) meeting.

As most of you know, ISO 13485–Quality Management Systems—Requirements for Regulatory Purposes is being revised. ISO 13485:201X, as the final revision is being referred to, is expected to be available in late 2015 or early 2016. Understandably, this is causing anxiety for medical device manufacturers, many of whom are still struggling to conform to the current version of the standard. With this in mind, let’s review the basics of the ISO: 13485. In future posts, we’ll examine why the standard is being updated, and the most significant changes you can expect to see.

It is a bit of a mystery to me that more is not made of the personal career advantages and knowledge gained from performing procedural assessments, audits and other quality management related functions. For me personally, this type of activity has been one of the key factors in my career progression and advancement.

An optimal quality management system (QMS) is the foundation for long-term regulatory compliance, especially for organizations working within strict U.S. Food and Drug Administration (FDA) and International Organization for Standardization (ISO) environments. Those lacking a solid quality infrastructure are simply not equipped to face the challenges of the regulatory environment and meet the demands of a competitive market.

A recent study by LNS Research shows that life sciences companies are facing an unprecedented demand for better and safer products. Results from LNS Research’s surveys of industry executives indicate the pressures life science organizations are facing and the new technologies and processes they are employing to meet rising needs.

Increasingly strict regulatory measures are drawing attention to the inadequacy of the systems and processes life sciences companies use to manage quality and production. A new eBook from LNS Research entitled A Road Map for Addressing Quality and Manufacturing Challenges in Life Sciences outlines some of the major challenges faced by life sciences companies and shows how prominent organizations are successfully handling those difficulties.

If you’re facing executive or organizational resistance to your plan to automate your quality system, you’re not alone. There are many quality and IT professionals who are in the same boat. They have the toughest time convincing senior management not just about the merits of an electronic quality management system (EQMS) but about the real value of quality.

Sun, spice, and romance—they’re everything I associate with summer. And I’m not talking about your love life, but your quality system. Indulge me for a moment and let me talk about the two things—quality software and romance—that preoccupy me most. I’m a full-time marketing writer and a newly published romance author. By day, I write about quality and compliance. By night, I write about people who live happily ever after (known as HEA to romance readers).

I was recently asked point-blank: What does MasterControl do? I was being interviewed for a medical device publication’s podcast, so the question was expected. Still, it forced me to mull over the company’s mission and accomplishments in the past 13 years under my leadership.